LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride liquid 
Provision Medical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

Directions

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel – 2 fl. oz Bottle Label

The Provision
First Aid
Line™

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 3500

Principal Display Panel – 2 fl. oz Bottle Label
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous18 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
methylparaben (UNII: A2I8C7HI9T)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-5100-00.118 L in 1 BOTTLE; Type 0: Not a Combination Product07/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/25/2022
Labeler - Provision Medical (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-5100)

Revised: 11/2013
Document Id: 804ba9d5-dab0-4491-b744-5a2b207383ed
Set id: c2b84d0e-1a6c-4468-bd40-b14f30f28b79
Version: 1
Effective Time: 20131111
 
Provision Medical